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  Intragastric bag for treating obesityUSPTO Application #: 20070276428Title: Intragastric bag for treating obesity Abstract: An apparatus and method comprising at least one intragastric member made of a digestive-resistant or substantially indigestible material that is introduced into a bag located in the gastric lumen of a mammal for the treatment of obesity. One or more intragastric members are loaded into a delivery tube in a partially compacted first configuration and delivered to an overtube. The overtube includes a proximal end, a distal end and a lumen configured to receive the intragastric members in the first configuration for delivery to the bag located in the gastric lumen wherein the intragastric member is expanded to a second configuration. The apparatus further comprises a constraining element engaged with the bag to secure the intragastric member upon delivery into the gastric lumen. (end of abstract) Agent: Brinks Hofer Gilson & Lione/chicago/cook - Chicago, IL, US Inventors: Frederick B. Haller, John A. Karpiel, Donagh O'Sullivan, Brian K. Rucker, Maximiliano Soetermans, William D. Voorhees USPTO Applicaton #: 20070276428 - Class: 606192000 (USPTO) Related Patent Categories: Surgery, Instruments, Internal Pressure Applicator (e.g., Dilator), Inflatable Or Expandible By Fluid The Patent Description & Claims data below is from USPTO Patent Application 20070276428. Brief Patent Description - Full Patent Description - Patent Application Claims
RELATED APPLICATIONS [0001] This application claims priority to provisional application No. 60/752,795 filed on Dec. 22, 2005, the entire disclosure of which is incorporated by reference herein. TECHNICAL FIELD [0002] This invention relates to medical devices, and more particularly to obesity treatment devices that can be placed in the stomach of a patient to reduce the size of the stomach reservoir or to place pressure on the inside surface of the stomach. BACKGROUND OF THE INVENTION [0003] It is well known that obesity is a very difficult condition to treat. Methods of treatment are varied, and include drugs, behavior therapy, and physical exercise, or often a combinational approach involving two or more of these methods. Unfortunately, results are seldom long term, with many patients eventually returning to their original weight over time. For that reason, obesity, particularly morbid obesity, is often considered an incurable condition. More invasive approaches have been available which have yielded good results in many patients. These include surgical options such as bypass operations or gastroplasty. However, these procedures carry high risks and are therefore not appropriate for most patients. [0004] In the early 1980s, physicians began to experiment with the placement of intragastric balloons to reduce the size of the stomach reservoir, and consequently its capacity for food. Once deployed in the stomach, the balloon helps to trigger a sensation of fullness and a decreased feeling of hunger. These balloons are typically cylindrical or pear-shaped, generally range in size from 200-500 ml or more, are made of an elastomer such as silicone, polyurethane, or latex, and are filled with air, water, or saline. While some studies demonstrated modest weight loss, the effects of these balloons often diminished after three or four weeks, possibly due to the gradual distension of the stomach or the fact that the body adjusted to the presence of the balloon. Other balloons include a tube exiting the nasal passage that allows the balloon to be periodically deflated and re-insufflated to better simulate normal food intake. However, the disadvantages of having an inflation tube exiting the nose are obvious. [0005] The experience with balloons as a method of treating obesity has provided uncertain results, and has been frequently disappointing. Some trials failed to show significant weight loss over a placebo, or were ineffective unless the balloon placement procedure was combined with a low-calorie diet. Complications have also been observed, such as gastric ulcers, especially with use of fluid-filled balloons, and small bowel obstructions caused by deflated balloons. In addition, there have been documented instances of the balloon blocking off or lodging in the opening to the duodenum, wherein the balloon may act like a ball valve to prevent the stomach contents from emptying into the intestines. [0006] Unrelated to the above-discussed methods for treating obesity, it has been observed that the ingestion of certain indigestible matter, such as fibers, hair, fuzzy materials, etc., can collect in the stomach over time, and eventually form a mass called a bezoar. In some patients, particularly children and the mentally handicapped, bezoars often result from the ingestion of plastic or synthetic materials. In many cases, bezoars can cause indigestion, stomach upset, or vomiting, especially if allowed to grow sufficiently large. It has also been documented that certain individuals having bezoars are subject to weight loss, presumably due to the decrease in the size of the stomach reservoir. Although bezoars may be removed endoscopically, especially in conjunction with a device known as a bezotome or bezotriptor, they, particularly larger ones, often require surgery. [0007] What is needed is an intragastric member that provides the potential weight loss benefits of a bezoar or intragastric balloon without the associated complications. Ideally, such a device should be well-tolerated by the patient, effective over a long period of time, sizable for individual anatomies, and easy to place and retrieve. The device will also provide the benefit of short-term weight loss thereby preparing the patient to safely undergo subsequent medical procedures involving surgery. SUMMARY OF THE INVENTION [0008] The foregoing problems are solved and a technical advance is achieved by an illustrative obesity treatment apparatus comprising at least one intragastric member such as an artificial bezoar made of a digestive-resistant or substantially indigestible material that is introduced into a bag located in the gastric lumen of a mammal in a first configuration. The intragastric member is typically inserted into a bag located in the gastric lumen in a partially compacted configuration, whereby it is then manipulated into, or allowed to assume, a second expanded configuration sufficiently large to maintain the bag within the reservoir of the stomach during normal activities and not be passed through the pylorus and into the intestines. Another advance is that the present invention can be effective at a smaller volume within the stomach compared to existing intragastric members, such as balloons. [0009] In one aspect of the invention, the obesity treatment apparatus comprises a bag disposed within the gastric lumen of a mammal and one or more intragastric members disposed within the bag. The intragastric members are sufficiently small to permit introduction of the one or more intragastric members into the bag. When the one or more intragastric members are disposed within the bag, the bag is configured to prevent the apparatus from passing through the mammal's pylorus. The one or more intragastric members are expandable from a first configuration to a second configuration upon contacting gastric fluid in the gastric lumen. Alternatively, the intragastric members may be self expanding or may be expanded upon the injection of a fluid such as saline. [0010] In another aspect of the invention, the obesity treatment apparatus comprises a plurality of intragastric members delivered to a bag. The plurality of intragastric members may be coupled together in a set or grouping within the bag located in the gastric lumen. The intragastric members may be individually loaded into the bag, and then grouped together using a coupling mechanism. Additional components may also be used with the coupling mechanism to facilitate placement of the set and/or separation of the individual intragastric members. For example, specially configured plastic or metal pieces can be attached to the line bundling the set of intragastric members together to enhance visibility of the line for cutting with an endoscopic scissor or scalpel, or to provide a hard surface against which the cutting instrument can be applied to more easily sever the line. Irrespective of whether the obesity treatment apparatus includes a single intragastric member, or a coupling of intragastric members, the principal requirement is that, once in the bag located in the gastric lumen, it attains a shape and size that prevents the bag from passing through or lodging in the pyloric sphincter. The bag may further include an inner member to seal the inner reservoir of the bag after delivery of the intragastric member into the bag. The bag may be secured with any suitable constraining means, such as a stopper, after the intragastric member is delivered into the bag. The bag may further comprise a porous or non-porous digestive resistant or substantially indigestible material, wherein the material can be woven or non-woven. The bag may also include one or more openings located along the surface, such as an open mesh configuration, that permits the passage of fluids therethrough. [0011] In another aspect of the invention, the obesity treatment device includes a delivery system to place the intragastric members within a bag located in the gastric lumen. In one embodiment, a bag is delivered to the gastric lumen. Then, one or more intragastric members are mounted on a delivery tube and secured with a releasing mechanism, such as a nylon thread, extending through the passageway of the delivery tube. A metal wire or loop is then withdrawn, severing the thread(s) and releasing the intragastric member(s) into the bag located in the gastric lumen. The individual intragastric members are then secured with a device such as a rubber patch pushed by an introduced metal tube or similar device. [0012] Other delivery systems of the present invention involve constraining the intragastric members, then releasing them into a bag within the gastric lumen. These can include pushing the intragastric member(s) from an outer delivery catheter, typically by use of a pusher member within the delivery catheter passageway. Other methods include constraining the intragastric member(s) with a splittable or dissolvable film or sheath that allows that device to be deployed in a compact configuration, then the intragastric member is allowed to expand when the outer wrapping or sheath is split by the operator, or when the outer wrapping or sheath is allowed to dissolve away over time in the stomach. The dissolvable film or sheath of the intragastric member comprises a material selected from the group consisting of cellulose, gelatin and glycerin. [0013] In still yet another aspect of the invention, the intragastric members can be precoupled together with a coupling mechanism, such as a nylon fishing line, prior to introduction into the gastric lumen. Because the volume of the grouping in the stomach increases over time due to mucous accumulation or other factors, a single device having the overall size of the grouping (e.g., four members grouped together) may not be readily removed. However, by severing the line comprising the coupling mechanism, the individual intragastric members of the grouping can be removed one at a time by using an endoscope and retrieval device. [0014] In still yet another aspect of the invention, the obesity treatment apparatus can comprise one or more intragastric members made of a digestive-resistant material loaded onto a delivery tube in a partially compacted first configuration, wherein the assembly is delivered through an overtube. The overtube includes a proximal end, a distal end, and a lumen configured to receive the intragastric members in the first configuration for delivery to the gastric lumen wherein the digestive-resistant material of the intragastric member is expanded to a second configuration within the bag. [0015] In still yet another aspect of the present invention, the obesity treatment apparatus can comprise a plurality of intragastric members having a small bead or ball-like structure deployed into a bag located in the stomach. The intragastric members can be inserted into the bag separately or together to displace volume in the gastric lumen. The bag is then secured by pushing a stopper or similar device onto the opening of the bag. Additionally, the intragastric members can be delivered utilizing an elastic band attached to the opening of the bag which is inserted over an overtube wherein the remainder of the bag is inverted into the lumen of the overtube. The intragastric members are subsequently pushed into the bag until the bag is filled. A coaxial outer tube or similar device can be utilized to remove the elastic band from the overtube and thereby secure the bag with the elastic band. The intragastric members may be removed by rupturing the bag resulting in the intragastric members passing through the gastrointestinal tract of the patient. Alternatively, the intragastric members can be removed by rupturing the bag and utilizing an overtube to suction the intragastric members from the bag and subsequently removing the bag through the overtube or endoscope with forceps or similar device. Further, the intragastric members can include a color coding to allow the intragastric members to be easily identified if the bag is prematurely ruptured. [0016] In still yet another aspect of the invention, a method of treatment of obesity in mammals can comprise the steps of positioning a bag within the gastric lumen of a mammal and loading at least one intragastric member into the bag, wherein when the at least one intragastric member is disposed within the bag, the bag is prevented from passing through the mammal's pylorus. The method further includes the additional step of positioning a delivery tube comprising the at least one intragastric member within a lumen of an overtube and advancing the at least one intragastric member through the lumen of the overtube into the bag located in the gastric lumen of the mammal. The method also includes the step of securing the at least one intragastric member in the bag located in the gastric lumen of the mammal. Upon delivery, the at least one intragastric member may be self expanding, may be expanded upon the injection of a fluid such as saline, or may be expanded upon contacting gastric fluid of the gastric lumen. [0017] In still yet another aspect of the invention, a method of treatment of obesity in mammals can comprise the steps of positioning a bag within the gastric lumen of a mammal and loading a plurality of intragastric members into the bag, wherein when the plurality of intragastric members are disposed within the bag, the bag is prevented from passing through the mammal's pylorus. The method further includes the additional step of positioning a delivery tube comprising the plurality of intragastric members within a lumen of an overtube and advancing the plurality of intragastric members through the lumen of the overtube into the gastric lumen of the mammal. The method also includes the step of securing the plurality of intragastric members in the bag located in the gastric lumen of the mammal. [0018] These and other advantages, as well as the invention itself, will become apparent in the details of construction and operation as more fully described below. Moreover, it should be appreciated that several aspects of the invention can be used with other types of intragastric devices or procedures used for the treatment of obesity. BRIEF DESCRIPTION OF THE DRAWINGS [0019] Several embodiments of the present invention will now be described by way of example with reference to the accompanying drawings, in which: Continue reading... 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